A.02 J&A NuVasive NTE_Redacted.pdf

Control Number: 20-RHCO-A-354

RFQ/RFP #: W91YTZ20Q0163

Limited Sources Justification or Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Regional Health Contracting Office – Atlantic - RHCO-A Fort Bragg Health Contracting Cell 6021 5th Street, Building 1469 Fort Belvoir, VA 22060-5505

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value:_

Name of Intended Contractor: NuVasive Clinical Services Monitoring, Inc.

Street Address: 10420 Little Patuxent Pkwy, Ste 250 City, State, Zip: Colombia, MA 21044-3638

Phone: POC: Lillian Martin @ (443) 393-8824 EMAIL: Lillian.Martin@nuvasive.com

Period of Performance: 01 June 2020 thru 30 November 2020

3. Description of Supplies/Services: For scheduled surgical procedures that facilitates the surgical process and risk by providing critical information and alerts to surgeons of potential harm or compromise to spinal cord or neural structures. NuVasive will be monitoring patients during surgery procedures. Medical supplies and services used during these surgical procedures are not to exceed the amount requested of

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: Known as intraoperative neurophysiological monitoring or IONM, it is a technique that changed the standards of care for patients by reducing the risk of permanent neurological damage. NuVasive CSM monitors the spinal cord or neural structures, providing information about the motor function. It can be used to help physicians assess potential damage or injury to the spinal cord due to ischemia, derotation and to verify the spinal cord pathways is intact.

NuVasive is changing the perception of back surgery through innovative solutions that are minimally disruptive to surrounding tissue. This results in reduced surgical times, minimal blood loss, a shorter stay and a quicker return to normal activities. If surgery is not approved; patient care will be diminished and patient will have to be sent to the network costing additional dollars to Womack Army Medical Center. Due to COVID-19 and 24 hour availability WAMC is sole-sourcing the requirement to NuVasive.

6. Actions to Increase Competition: Sources sought will be posted on the Federal Business Opportunities (FedBizOpps) website for increased competition.

7. Market Survey: Market Research conducted in accordance with FAR Part 10. I researched by using the General NAICS code 621399 and found no small business contractors having the capability to provide the parts. On 13 March 2020 an on-line search was conducted on the Small Business Administration (SBA) Quick Market Research and nothing was revealed using the words “Intraoperative Monitoring” and “Spinal Cord Monitoring.”

Results of the search using the key words “Intraoperative Monitoring”:

Economic Group Number of Firms Found Service-Disabled Veteran 0 Currently SDB Certified 0 Currently HUBZone Certified 0 Currently 8(a) Certified 0 Woman or Women Owned 2 Veteran 1

Results of the search using the NAICS code 541930:

Economic Group Number of Firms Found Service-Disabled Veteran 420 Currently SDB Certified 26 Currently HUBZone Certified 119 Currently 8(a) Certified 166 Woman or Women Owned 1726 Veteran 555

The medical supplies and services are not available on the General Schedule Administration (GSA) contract schedule.

8. Procurement History: Multiple Credit Card Purchases

Previous Contract or Purchase Order Number: or

NTE # W91YTZ-19-P-0405 in the amount of $84K NTE # W91YTZ-20-P-0045 in the amount of $90K

Previously competed? N/A No Yes Previous authority for less than Full & Open Competition:

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

I certify the required services and supplies are not available using mandatory sources and delivery cannot be made by the required delivery date.

Submitted By: Christen M. Barnhill Position Title : SGG CPT, AN, Surgical Logistics

Email address: christen m.barnhill. i @mail.mil Date: 10 Oct 2018

Stefan Lin

SGT

Stefan.lin.mil@mail.mil 13 March 2020

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: Donna L. Blossom Position Title: Contracting Officer

Email address:

Date: